Senior Clinical Trial Manager

JOB DESCRIPTION:

• •Plan, coordinate and oversee all start-up activities of internal disciplines (Drug supply, Regulatory, Safety, Data Management etc.) and being the main contact (supervise, steer etc.) for involved CROs and other external vendors, if applicable
• •Agree and/or ensure implementation of study principles and deliverables (safety, timelines, quality, milestones, budget, etc.) and follow-up to guarantee adherence
• •Facilitate communication and ensure adequate collaboration between all involved parties
• •Communicate effectively processes to in-/external service groups and clients in accordance with all applicable procedures (e.g. BIOM, Task List etc.)
• •Participate in teams related to trial conduct (e.g. Clinical Study team, Extended Joint Abbott- CRO Clinical Team, Drug supply team etc.) and organize/attend external key study meetings (Kick-off meeting, CRA meeting, Investigator meeting, etc) as applicable
• •Read, review and/or assist in preparation of core project documents (e.g. Investigator Brochure, Concise Clinical Development Plan, Protocol, Informed Consent Form) as applicable
• •Review key Clinical Trial Management strategies like: Communication plan / Feasibility / Patient & Site recruitment / Drug supply / EC&RA Submission, etc.

Oversee and manage with the CRO Project Manager the study conduct in order to ensure adequate and timely delivery of study data and documentation in Trial Master File (TMF):

• •Use efficiently tools to monitor status of e.g. patient recruitment and take corrective action if necessary
• •Ensure respect of agreed deliverables, and communicate efficiently within the teams (timelines, milestones, budget, quality)
• •Co-coordinate timely availability of all supplies important for the conduction of trials, including the re-supply of sites
• •Monitor data collection, cleaning and data transfer with respect to completeness, quality and timely delivery of the final results
• •Review audit reports and ensure issues are resolved
• •Participate in strategic decision making to improve recruitment
• •Apply operational risk management plan (if applicable)
• •Support activities to generate study report / dossier
• •Supervise and monitor the transfer and archiving of the clinical file (e.g. TMF)

The base pay for this position is

N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

EPD Established Pharma

LOCATION:

India > Mumbai : Mumbai Development Center - EPD

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)